Dose-finding Study of Moxidectin for Treatment of Scabies

Inclusion criteria

• Aged ≥ 18 years.
• Provision of written informed consent.
• Parasitologically confirmed active Sarcoptes scabiei infestation, defined as the presence of at least two lesions (which may include burrows), each containing at least one live (internal and/or external structures discernable) adult Sarcoptes scabiei mite observed by reflectance confocal microscopy.
• Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening and until 6 months after treatment with study product.

Exclusion criteria

• History of chronic or recurring dermatologic disease (other than scabies) that could interfere with the diagnosis and/or subsequent clinical assessment of scabies.
• Diagnosis of crusted/Norwegian scabies or scabies that, in the opinion of the Investigator, would require treatment with more than one standard of care (e.g. scabies requiring concurrent topical and oral treatment).
• Received any treatment for scabies within 7 days of Screening, including but not limited to permethrin, ivermectin, benzyl benzoate, lindane, crotamiton, malathion, and/or tea tree oil.
• Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that would put the subject at increased risk from participating in the study or confound study evaluations.
• Poor venous access.
• Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
• Body Mass Index over 35 kg/m2.
• Clinically relevant abnormal findings in vital signs, 12-lead electrocardiogram (ECG), or physical examination at Screening and/or Baseline in the opinion of the Investigator.
• Clinically relevant laboratory abnormalities at Screening, including:

• alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of reference range;
• creatinine > 2.0 milligrams per deciliter (mg/dL);
• hemoglobin < 9.5 g/dL (female) or <10.5 g/dL (male);
• amylase > 2.0 x upper limit of reference range.
• Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin.
• Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids, or use of topical steroids for 7 out of the 14 days prior to Screening.
• Subjects with known or suspected Loa loa coinfection.
• Difficulty swallowing tablets.
• Pregnant or breastfeeding, or planning to become pregnant.
• Known or suspected alcohol or illicit substance abuse.
• Unwilling, unlikely or unable to comply with all protocol specified assessments.
• Previous enrolment and treatment with moxidectin in this study.